Biopsy device with sterile sleeve

ABSTRACT

A sterile cover assembly is for a biopsy device. The biopsy device includes a reusable holster including a housing and driving mechanism. The driving mechanism is for driving a cutter in a needle of a probe. The housing is adapted to releasably couple to the probe. The sterile cover assembly includes a sleeve and a flexible sterile cover. The sleeve is configured to receive at least a portion of the housing of the reusable holster. The sterile cover is coupled to the sleeve and is configured to cover the housing of the holster.

This application claims priority to U.S. Provisional Patent App. No.62/505,571 entitled “Biopsy Device with Sterile Sleeve,” filed May 12,2017, the disclosure of which is incorporated by reference herein.

BACKGROUND

A biopsy is the removal of a tissue sample from a patient to enableexamination of the tissue for signs of cancer or other disorders. Tissuesamples may be obtained in a variety of ways using various medicalprocedures involving a variety of the sample collection devices. Forexample, biopsies may be open procedures (surgically removing tissueafter creating an incision) or percutaneous procedures (e.g. by fineneedle aspiration, core needle biopsy, or vacuum assisted biopsy). Afterthe tissue sample is collected, the tissue sample may be analyzed at alab (e.g. a pathology lab, biomedical lab, etc.) that is set up toperform the appropriate tests (such as histological).

Biopsy samples have been obtained in a variety of ways in variousmedical procedures including open and percutaneous methods using avariety of devices. For instance, some biopsy devices may be fullyoperable by an operator using a single hand, and with a singleinsertion, to capture one or more biopsy samples from a patient. Inaddition, some biopsy devices may be tethered to a vacuum module and/orcontrol module, such as for communication of fluids (e.g., pressurizedair, saline, atmospheric air, vacuum, etc.), for communication of power,and/or for communication of commands and the like. Other biopsy devicesmay be fully or at least partially operable without being tethered orotherwise connected with another device.

The state of the art for breast biopsy is vacuum-assisted breast biopsy.A current textbook in this area is “Vacuum-Assisted Breast Biopsy withMammotome®” available Nov. 11, 2012, copyright 2013 by Devicor MedicalGermany GmBh, published in Germany by Springer Medizin Verlag, Authors:Markus Hahn, Anne Tardivon and Jan Casselman, ISBN 978-3-642-34270-7.

Biopsy devices may be used under ultrasound image guidance, stereotactic(X-ray) guidance, MRI guidance, Positron Emission Mammography (“PEM”guidance), Breast-Specific Gamma Imaging (“BSGI”) guidance, orotherwise. Each procedure has its own methodology based on the form ofimaging guidance used.

Known biopsy devices and biopsy system components are disclosed in U.S.Pat. No. 5,526,822, entitled “Method and Apparatus for Automated Biopsyand Collection of Soft Tissue,” issued Jun. 18, 1996; U.S. Pat. No.6,017,316, entitled “Vacuum Control System and Method for AutomatedBiopsy Device,” issued Jan. 25, 2000; U.S. Pat. No. 6,086,544, entitled“Control Apparatus for an Automated Surgical Biopsy Device,” issued Jul.11, 2000; U.S. Pat. No. 6,162,187, entitled “Fluid Collection Apparatusfor a Surgical Device,” issued Dec. 19, 2000; U.S. Pat. No. 7,442,171,entitled “Remote Thumbwheel for a Surgical Biopsy Device,” issued Oct.8, 2008; U.S. Pat. No. 7,938,786, entitled “Vacuum Timing Algorithm forBiopsy Device,” issued May 10, 2011; U.S. Pat. No. 8,118,755, entitled“Biopsy Sample Storage,” issued Feb. 1, 2012; U.S. Pat. No. 8,532,747,entitled “Biopsy Marker Delivery Device,” issued Sep. 10, 2013; U.S.Pat. No. 8,764,680, entitled “Handheld Biopsy Device with NeedleFiring,” issued on Jun. 11, 2014; U.S. Pat. No. 8,858,465, entitled“Biopsy Device with Motorized Needle Firing,” issued Oct. 14, 2014; U.S.Pat. No. 9,326,755, entitled “Biopsy Device Tissue Sample Holder withBulk Chamber and Pathology Chamber,” issued May 3, 2016; and U.S. Pat.No. 9,486,186, entitled “Biopsy Device With Slide-In Probe,” issued Nov.8, 2016. The disclosure of each of the above-cited U.S. Patents isincorporated by reference herein.

Additionally known biopsy devices and biopsy system components aredisclosed in U.S. Pub. No. 2006/0074345, entitled “Biopsy Apparatus andMethod,” published Apr. 6, 2006 and now abandoned; U.S. Pub. No.2010/0152610, entitled “Hand Actuated Tetherless Biopsy Device withPistol Grip,” published Jun. 17, 2010, now abandoned; U.S. Pub. No.2010/0160819, entitled “Biopsy Device with Central Thumbwheel,”published Jun. 24, 2010, now abandoned; and U.S. Pub. No. 2013/0324882,entitled “Control for Biopsy Device,” published Dec. 5, 2013. Thedisclosure of each of the above-cited U.S. Patent ApplicationPublications is incorporated by reference herein.

U.S. Pub. No. 2014/0275999, entitled “Biopsy device” published Sep. 18,2014, and U.S. Pub. No. 2016/0183928, entitled “Biopsy Device,”published Jun. 30, 2016, both describe some aspect of a biopsy deviceincluding a probe, a holster, and a tissue sample holder for collectingtissue samples. The probe includes a needle and a hollow cutter. Thetissue sample holder includes a housing having a plurality of chambersthat are configured to receive a plurality of strips connected by atleast one flexible member. The flexible member is configured to permitthe strips to pivot relative to each other such that the strips canshift between a flat configuration and an arcuate configuration. Thetissue sample holder is rotatable to successively index each chamber tothe cutter lumen such that tissue samples may be collected in thestrips. The strips may be removed from the tissue sample holder andplaced in a tissue sample holder container for imaging of tissuesamples.

While several systems and methods have been made and used for obtainingand processing a biopsy sample, it is believed that no one prior to theinventor has made or used the invention described in the appendedclaims.

BRIEF DESCRIPTION OF THE DRAWINGS

It is believed the present invention will be better understood from thefollowing description of certain examples taken in conjunction with theaccompanying drawings, in which like reference numerals identify thesame elements and in which:

FIG. 1 depicts a perspective view of an exemplary biopsy deviceincluding an exemplary removable cover assembly coupled to a portion ofthe biopsy device;

FIG. 2 depicts a partially exploded side elevation view of the biopsydevice of FIG. 1, with the removable cover assembly separated into innerand outer retainers and decoupled from a holster;

FIG. 3 depicts a perspective view of the inner and outer retainers ofthe removable cover assembly of FIG. 1, in a decoupled state;

FIG. 4 depicts a perspective view of an exemplary alternative inner andouter retainers of the removable cover assembly of FIG. 1, in a coupledstate;

FIG. 5 depicts an exploded view of the sterile sleeve assembly of FIG.1, with the removable cover assembly including an exemplary flexiblesterile cover, with the removable cover assembly decoupled from theholster;

FIG. 6 depicts a perspective view of the biopsy device of FIG. 1 coupledto the removable cover assembly and contained within the flexiblesterile cover;

FIG. 7 depicts a side cross-sectional view of the biopsy device of FIG.1, with the cross-section taken along line 7-7 of FIG. 1;

FIG. 8 depicts a side cross-sectional view of the holster latch coupledto the biopsy device of FIG. 1, with the flexible sterile coverpositioned therebetween, with the cross-section taken along line 8-8 ofFIG. 1;

FIG. 9 depicts a bottom cross-sectional view of the biopsy device ofFIG. 1, with the cross-section taken along line 9-9 of FIG. 7;

FIG. 10 depicts a perspective cross-sectional view of the outer retainercoupled to the inner retainer of the removable cover assembly of FIG. 1,with the flexible sterile cover positioned therebetween, with thecross-section taken along line 10-10 of FIG. 6;

FIG. 11 depicts a perspective view of an exemplary alternative sleevering that can used with the flexible sterile cover of FIG. 5;

FIG. 12 depicts another perspective view of the sleeve ring of FIG. 11;

FIG. 13 depicts still another perspective view of the sleeve ring ofFIG. 11, the sleeve ring in a flexed configuration;

FIG. 14 depicts yet another perspective view of the sleeve ring of FIG.11, with the flexible sterile cover secured thereto and in an extendedconfiguration; and

FIG. 15 depicts yet another perspective view of the sleeve ring of FIG.11, with the flexible sterile cover secured thereto and in a compressedconfiguration; and

FIG. 16 depicts a perspective view of the sleeve ring of FIG. 11, withthe inner and outer retainers of FIG. 2 and the flexible sterile coverof FIG. 5; and

FIG. 17 depicts a side cross-sectional view of the sleeve ring of FIG.11, with the inner and outer retainers of FIG. 2 and the flexiblesterile cover of FIG. 5, the cross-section taken along line 17-17 ofFIG. 16.

The drawings are not intended to be limiting in any way, and it iscontemplated that various embodiments of the technology may be carriedout in a variety of other ways, including those not necessarily depictedin the drawings. The accompanying drawings incorporated in and forming apart of the specification illustrate several aspects of the presenttechnology, and together with the description serve to explain theprinciples of the technology; it being understood, however, that thistechnology is not limited to the precise arrangements shown.

DETAILED DESCRIPTION OF THE INVENTION

The following description of certain examples of the technology shouldnot be used to limit its scope. Other examples, features, aspects,embodiments, and advantages of the technology will become apparent tothose skilled in the art from the following description, which is by wayof illustration, one of the best modes contemplated for carrying out thetechnology. As will be realized, the technology described herein iscapable of other different and obvious aspects, all without departingfrom the technology. Accordingly, the drawings and descriptions shouldbe regarded as illustrative in nature and not restrictive.

I. Exemplary Biopsy Device

FIG. 1 shows an exemplary biopsy device (10) that may be used in abreast biopsy system. Biopsy device (10) of the present examplescomprises a probe (100) and a holster (200). A needle (110) extendsdistally from probe (100) and is inserted into a patient's tissue toobtain tissue samples. These tissue samples are deposited in a tissuesample holder (150) at the proximal end of probe (100).

Holster (200) of the present example is selectively attachable to probe(100) to provide actuation of various components within probe (100). Inthe present configuration, holster (200) is a reusable component, whileprobe (100) and tissue sample holder (150) are disposable. It should beunderstood that the use of the term “holster” herein should not be readas requiring any portion of probe (100) to be inserted into any portionof holster (200). For instance, in the present example, holster (200)may include a retention feature (240) that is received by probe (100) toreleasably secure probe (100) to holster (200). Probe (100) alsoincludes a set of resilient tabs (not shown) or other suitable releasefeatures that may be pressed inwardly to disengage retention feature(240), such that an operator may simultaneously depress both of the tabsthen pull probe (100) rearwardly and away from holster (200) to decoupleprobe (100) from holster (200). Of course, a variety of other types ofstructures, components, features, etc. (e.g., bayonet mounts, latches,clamps, clips, snap fittings, etc.) may be used to provide removablecoupling of probe (100) and holster (200). Furthermore, in some biopsydevices (10), probe (100) and holster (200) may be of unitary orintegral construction, such that the two components cannot be separated.By way of example only, in versions where probe (100) and holster (200)are provided as separable components, probe (100) may be provided as adisposable component, while holster (200) may be provided as a reusablecomponent. Still other suitable structural and functional relationshipsbetween probe (100) and holster (200) will be apparent to those ofordinary skill in the art in view of the teachings herein.

Some variations of biopsy device (10) may include one or more sensors(not shown), in probe (100) and/or in holster (200), that is/areconfigured to detect when probe (100) is coupled with holster (200).Such sensors or other features may further be configured to permit onlycertain types of probes (100) and holsters (200) to be coupled together.In addition or in the alternative, such sensors may be configured todisable one or more functions of probes (100) and/or holsters (200)until a suitable probe (100) and holster (200) are coupled together. Inone merely illustrative example, probe (100) includes a magnet (notshown) that is detected by a Hall effect sensor (not shown) or someother type of sensor in holster (200) when probe (100) is coupled withholster (200). As yet another merely illustrative example, coupling ofprobe (100) with holster (200) may be detected using physical contactbetween conductive surfaces or electrodes, using RFID technology, and/orin numerous other ways as will be apparent to those of ordinary skill inthe art in view of the teachings herein. Of course, such sensors andfeatures may be varied or omitted as desired.

Biopsy device (10) of the present example is configured for handheld useand be used under ultrasonic guidance. Of course, biopsy device (10) mayinstead be used under stereotactic guidance, MRI guidance, PEM guidance,BSGI guidance, or otherwise. It should also be understood that biopsydevice (10) may be sized and configured such that biopsy device (10) maybe operated by a single hand of an operator. In particular, an operatormay grasp biopsy device (10), insert needle (110) into a patient'sbreast, and collect one or a plurality of tissue samples from within thepatient's breast, all with just using a single hand. Such tissue samplesmay be deposited in tissue sample holder (150), and later retrieved fromtissue sample holder (150) for analysis. While examples described hereinoften refer to the acquisition of biopsy samples from a patient'sbreast, it should be understood that biopsy device (10) may be used in avariety of other procedures for a variety of other purposes and in avariety of other parts of a patient's anatomy (e.g., prostate, thyroid,etc.). Various exemplary components, features, configurations, andoperabilities of biopsy device (10) will be described in greater detailbelow; while other suitable components, features, configurations, andoperabilities will be apparent to those of ordinary skill in the art inview of the teachings herein. Alternatively, an operator may graspbiopsy device (10) with more than one hand and/or with any desiredassistance. In still other examples, biopsy device (10) can beconfigured to be secured to a table or other fixture without handheldoperation.

In some settings, whether biopsy device (10) is handheld or mounted to afixture, the operator may capture a plurality of tissue samples withjust a single insertion of needle (110) into the patient's breast. Suchtissue samples may be deposited in tissue sample holder (150), and laterretrieved from tissue sample holder (150) for analysis. While examplesdescribed herein often refer to the acquisition of biopsy samples from apatient's breast, it should be understood that biopsy device (10) may beused in a variety of other procedures for a variety of other purposesand in a variety of other parts of a patient's anatomy (e.g., prostate,thyroid, etc.). Various exemplary components, features, configurations,and operabilities of biopsy device (10) will be described in greaterdetail below; while other suitable components, features, configurations,and operabilities will be apparent to those of ordinary skill in the artin view of the teachings herein.

As seen in FIG. 2, holster (200) of the present example includes anouter housing (202) that is configured to at least partially encompassthe internal components of holster (200). Although not shown, it shouldbe understood that holster (200) of the present example includes one ormore motors and/or other actuators that are configured to drive variouscomponents of probe. To communicate power or movement to probe (100),holster (200) can include one or more gears. For instance, in someexamples, one or more gears at least partially extend through an openingin outer housing (202). The opening in outer housing (202) can beconfigured to align with a corresponding opening associated with probe(100) to thereby permit the one or more gears of holster (200) to meshwith one or more corresponding gears of probe (100).

Although not shown, it should be understood that holster (200) may alsoinclude various cables that are configured to couple holster (200) to acontrol module or another control feature. Suitable cables may includeelectrical cables, rotary drive cables, pneumatic cables, or somecombination thereof. Accordingly, it should be understood that in someexamples, internal components within holster (200) may be powered byelectrical power (electrical cables), rotary power (rotary drive cable),and/or pneumatic power (pneumatic cables). Alternatively, in someexamples the cables are omitted entirely and holster (200) can bebattery powered with motors and vacuum pumps being entirely containedwithin holster (200).

As described above with respect to holster (200), probe (100) isselectively couplable to holster (200) so that holster (200) may providepower or otherwise actuate probe (100). As can be best seen in FIG. 2,holster (200) includes a locating feature (210) at the distal end ofholster (200). Holster (200) further includes a retention feature (240)at the proximal end of holster (200). Locating feature (210) is sizedand configured to securely fit holster (200) into a correspondingreceiving feature (120) of probe (100) when holster (200) is attached toan outer housing of probe (100). Retention feature (240) is sized andconfigured to securely attach holster (200) onto probe (100) by latchingagainst a catch (142) of probe (100). Catch (142) includes a bore,aperture, or opening near a proximal end of probe (100) configured toreceive retention feature (240). Latch (140) of probe (100) ispositioned proximally to catch (142) and is in mechanical communicationwith catch (142) to thereby be operable to disengage catch (142) fromretention feature (240) of holster (200). Upon actuating latch (140) anddisengaging catch (142) from retention feature (240), holster (200)becomes decoupled from probe (100). Of course, a variety of other typesof structures, components, features, etc. (e.g., bayonet mounts, clamps,clips, snap fittings, etc.) may be used to provide removable coupling ofprobe (100) and holster (200). While only a few exemplary attachmentconfigurations have been described for holster (200), other variousconfigurations may be provided as will be apparent to those of ordinaryskill in the art in view of the teachings herein. Furthermore, in somebiopsy devices (10), probe (100) and holster (200) may be of unitary orintegral construction, such that the two components cannot be separated.By way of example only, in versions where probe (100) and holster (200)are provided as separable components, probe (100) may be provided as adisposable component, while holster (200) may be provided as a reusablecomponent. Still other suitable structural and functional relationshipsbetween probe (100) and holster (200) will be apparent to those ofordinary skill in the art in view of the teachings herein.

Probe (100) of the present example further includes a needle (110)extending distally from probe (100) that is inserted into a patient'stissue to obtain tissue samples. These tissue samples are deposited in atissue sample holder (150) at the proximal end of probe (100). In someexamples, a vacuum control module (not shown) is coupled with probe(100) via a valve assembly (not shown) and tubes (not shown), which isoperable to selectively provide vacuum, saline, atmospheric air, andventing to probe (100). By way of example only, the internal componentsof the valve assembly may be configured and arranged as described inU.S. Pat. Pub. No. 2013/0218047, entitled “Biopsy Device ValveAssembly,” published Aug. 22, 2013, the disclosure of which isincorporated by reference herein.

Needle (110) of the present example comprises a cannula (113) having apiercing tip (112), and a lateral aperture (114) located proximal to tip(112). Tissue piercing tip (112) is configured to pierce and penetratetissue, without requiring a high amount of force, and without requiringan opening to be pre-formed in the tissue prior to insertion of tip(112). Alternatively, tip (112) may be blunt (e.g., rounded, flat, etc.)if desired. By way of example only, tip (112) may be configured inaccordance with any of the teachings in U.S. Pat. No. 8,801,742,entitled “Needle Assembly and Blade Assembly for Biopsy Device,” filedJun. 1, 2011, the disclosure of which is incorporated by referenceherein. As another merely illustrative example, tip (112) may beconfigured in accordance with at least some of the teachings in U.S.Pat. No. 9,486,186, entitled “Biopsy Device with Slide-In Probe,” issuedNov. 8, 2016, the disclosure of which is incorporated by referenceherein. Other suitable configurations that may be used for tip (112)will be apparent to those of ordinary skill in the art in view of theteachings herein.

Lateral aperture (114) is sized to receive prolapsed tissue duringoperation of device (10). A hollow tubular cutter (not shown) having asharp distal edge (not shown) is located within needle (110). Cutter isoperable to rotate and translate relative to needle (110) and pastlateral aperture (114) to sever a tissue sample from tissue protrudingthrough lateral aperture (114). For instance, cutter may be moved froman extended position to a retracted position, thereby “opening” lateralaperture (114) to allow tissue to protrude therethrough; then from theretracted position back to the extended position to sever the protrudingtissue.

In some examples, it may be desirable to rotate needle (110) to orientlateral aperture (114) at a plurality of desired angular positions aboutthe longitudinal axis of needle (110). In the present example, needle(110) can be rotated by a motor disposed in probe (100) or holster(200). In other examples, needle (110) is manually rotatable by athumbwheel on probe (100) or needle hub directly overmolded onto needle(110). Regardless, it should also be understood that, as with othercomponents described herein, needle (110) may be varied, modified,substituted, or supplemented in a variety of ways; and that needle (110)may have a variety of alternative features, components, configurations,and functionalities. For instance, needle (110) may be constructed andoperable in accordance with at least some of the teachings of U.S. Pat.No. 9,345,457, issued May 24, 2016, the disclosure of which isincorporated by reference herein; and/or in accordance with theteachings of any other reference cited herein.

Tissue sample holder (150) is selectively coupleable to the proximal endof probe (100). In some examples, tissue sample holder (150) may beconfigured to operate in two discrete sample collection modes—a bulktissue collection mode and an individual tissue collection mode. By wayof example only, tissue sample holder (150) may be constructed andoperable in accordance with at least some of the teachings of U.S.application Ser. No. 15/829,499, entitled “Multi-Chamber Tissue SampleCup for Biopsy Device,” filed on Dec. 1, 2017, the disclosure of whichis incorporated by reference herein. By way of further example, tissuesample holder (150) may be constructed and operable in accordance withat least some of the teachings of any of the other references citedherein; and/or in any other suitable fashion.

The distal portion of probe (100) further includes a tissue samplewindow (139) disposed proximally of the distal end of probe (100). Insome examples, tissue sample window (139) exposes a gate assembly (notshown), such that the gate assembly is visible to an operator thoughprobe (100). The gate assembly is generally configured to selectivelyarrest movement of the severed tissue sample within the fluid conduitbetween the cutter and the tissue sample holder (150). The gate assemblyis enables the operator to temporarily cease progression of tissuesamples for visual inspection though a sample window (139) of probe(100). At least a portion of the gate assembly is coupled to cutter tocommunicate rotational and translational motion of gate assembly tocutter. Thus, it should be understood that rotation and translation ofcutter drive member (not shown) results in corresponding rotation andtranslation of cutter via the coupling between at least a portion of thegate portion and at least a portion of the gate assembly. In someexamples, the gate assembly may be constructed in accordance with theteachings of U.S. application Ser. No. 15/829,483, entitled “Apparatusto Allow Biopsy Sample Visualization During Tissue Removal,” filed onDec. 1, 2017, the disclosure of which is incorporated by referenceherein. Alternatively, probe (100) may simply lack a gate assembly, suchthat severed tissue samples are permitted to travel freely to tissuesample holder (150).

II. Exemplary Sterile Cover Assembly

As described above, holster (200) of the present example is configuredas a reusable portion, while probe (100) is configured as a disposableportion. In some contexts, it may be desirable to maintain sterility ofreusable components during a biopsy procedure. Accordingly, in someinstances it may be desirable to use holster (200) in connection withcertain shielding features to maintain the sterility of holster (200),while also maintaining functionality of holster (200). Although somesuitable features for maintaining the sterility of holster (200) aredescribed below, it should be understood that other alternativeconfigurations may be used in connection with biopsy device (10) withoutdeparting from the teachings herein.

FIG. 1 shows an exemplary removable cover assembly (300) of the presentexample removably coupled to holster (200) to provide sterilityprotection of the various components of holster (200) and outer housing(202) of holster (200). In the present configuration, holster (200) is areusable component, while removable cover assembly (300) is disposable.It should be understood that the use of the term “cover” herein shouldnot be read as only requiring removable cover assembly (300) to beplaced on top of outer housing (202) of holster (200). For instance, aswill be discussed in greater detail below, in the present exampleremovable cover assembly (300) includes a set of sleeves (310, 320, 330)that engage holster (200) to secure removable cover assembly (300) tobiopsy device (10). Removable cover assembly (300) is sized and shapedto encase outer housing (202) of holster (200) and the variouscomponents of holster (200). Removable cover assembly (300) comprises aninner retainer (310) and an outer retainer (320). In its assembledconfiguration, inner retainer (310) is operable to contain holster (200)and outer retainer (320) is configured to encase or enclose at least aportion of inner retainer (310) while inner retainer (310) encases orenclose at least a portion of holster (200). In some versions, as willbe discussed in further detail below, removable cover assembly (300) mayfurther include a flexible sterile cover (330) configured to encase orenclose at least a portion of inner retainer (310) and at least aportion of holster (200) prior to their insertion within outer retainer(320).

As best seen in FIG. 2, inner retainer (310) includes a proximal innerretainer opening (314), a distal inner retainer opening (316), and a topinner retainer opening (318). Inner retainer (310) further includes aninner retainer channel (312) contained within the outer housing of innerretainer (310) and positioned between inner retainer openings (314,316). Inner retainer (310) is sized and shaped to slidably receiveholster (200) within inner retainer channel (312) through proximal innerretainer opening (314). Inner retainer (310) has a longitudinal lengthless than a longitudinal length of holster (200) such that a proximalend (204) of holster (200) extends proximally from proximal innerretainer opening (314).

Similar to inner retainer (310), outer retainer (320) includes aproximal outer retainer opening (324), a distal outer retainer opening(326), and a top outer retainer opening (328). Outer retainer (320)further includes an outer retainer channel (322) contained within theouter housing of outer retainer (320) and positioned between outerretainer openings (324, 326). Outer retainer (320) is sized and shapedto slidably receive inner retainer (310) within outer retainer channel(322) through proximal outer retainer opening (324). Outer retainer(320) has a longitudinal length less than the longitudinal length ofinner retainer (310) such that a proximal end of inner retainer (310)extends proximally from proximal outer retainer opening (324). It shouldbe understood that the longitudinal lengths of sleeves (310, 320) inrelation to holster (200) may vary from those depicted as other suitablelengths for will be apparent to those of ordinary skill in the art.

In some variations of holster (200), outer housing (202) may include aseries of buttons (not shown) or other operating control features on anoperating panel (220) that allow an operator to actuate biopsy device(10) during a procedure. In this instance, it may be beneficial for theoperator to maintain continued access to operating panel (220) whileholster (200) is contained within removable cover assembly (300). In thepresent example, as seen in FIG. 3, top inner retainer opening (318) ispositioned along the outer housing of inner retainer (310) and proximalto distal inner retainer opening (316). Top inner retainer opening (318)is sized and shaped to correspond with the size and shape of operatingpanel (220) to thereby provide continued access to operating panel (220)despite the positioning of holster (200) within inner retainer (310).Similarly, top outer retainer opening (328) is positioned along theouter housing of outer retainer (320) and proximal to distal outerretainer opening (326). Top outer retainer opening (328) is sized andshaped to correspond with the size and shape of top inner retaineropening (318) and operating panel (220) to provide continued access ofoperating panel (220) despite the positioning of holster (200) withinsleeves (310, 320).

Operating panel (220) can include numerous operator interface features.For instance, in some examples operating panel (220) includes threeoutwardly protruding buttons. In such examples, each button can beassigned to activate a discrete operational feature. By way of exampleonly, in some examples one button triggers opening and closing oflateral aperture (114), another button activates vacuum to pull fluidfrom needle (110), and another button can activate transport of a tissuesample through needle (110). Although certain discrete functions aredescribed herein in relation to the buttons, it should be understoodthat in other examples numerous alternative functions may be controlledwith buttons. In addition, in some examples buttons may be programmablesuch that an operator may assign a function to each button from aplurality of different functions. In still other examples, the buttonsmay be eliminated entirely and replaced with one or more alternativecontrol features such as a touchpad, a sensor, and/or etc.

As discussed above, holster (200) may further include one more or gears(not shown) or other interface features that provide for the mechanicalcommunication between probe (100) and holster (200) when coupledtogether. In this instance, it may be beneficial for the one or moregears of holster (200) to maintain continued communication with probe(100) while holster (200) is contained within removable cover assembly(300). In the present example, as seen in FIGS. 3-4, sleeves (310, 320)include bottom sleeve openings (315, 325) along a bottom surface ofsleeves (310, 320) opposite of top sleeve openings (318, 328). Inparticular, bottom sleeve openings (315) of inner retainer (310) arepositioned along the outer housing of inner retainer (310) and proximalto distal inner retainer opening (316). Bottom inner retainer openings(318) are sized and shaped to correspond with the size and shape of theone or more gears (not shown) of holster (200) to provide the one ormore gears continued access to probe (100) despite the positioning ofholster (200) within inner retainer (310). Similarly, bottom outerretainer openings (325) are positioned along the outer housing of outerretainer (320) and proximal to distal outer retainer opening (326).Bottom outer retainer openings (325) are sized and shaped to correspondwith the size and shape of bottom inner retainer openings (315) and theone or more gears of holster (200) to provide them continued access toprobe (100) despite the positioning of holster (200) within sleeves(310, 320).

As previously discussed, holster (200) is configured to couple to probe(100) through the engagement of locating feature (210) of holster (200)with receiving feature (120) of probe (100) and retention feature (240)of holster (200) with catch (142) of probe (100). To accommodate thecontinued ability for holster (200) to removably attach to probe (100),despite being positioned within removable cover assembly (300), sleeves(310, 320) include sleeve openings (314, 316, 324, 326) on both distaland proximal ends, respectively, as seen in FIG. 4. In particular,sleeves (310, 320) include distal sleeve openings (316, 326) which aresized and shaped to receive the distal end of holster (200) when holster(200) is slidably received within removable cover assembly (300). Inthis instance, locating feature (210) may extend through distal sleeveopenings (316, 326) and beyond sleeves (310, 320) to thereby allowlocating feature (210) to engage receiving feature (120) despite holster(200) being protectively contained within sleeves (310, 320).

Furthermore, sleeves (310, 320) include proximal sleeve openings (314,324) which are sized and shaped to allow the distal end of holster (200)to extend beyond sleeves (310, 320) when holster (200) is slidablyreceived within removable cover assembly (300). In this instance,retention feature (240) is positioned proximally from proximal sleeveopenings (314, 324) and outside of sleeves (310, 320) to thereby allowretention feature (240) to engage catch (142) despite holster (200)being protectively contained within sleeves (310, 320). Alternatively,sleeves (310, 320) may include sleeve locating features (313, 323) atdistal sleeve openings (316, 322), respectively as seen in FIG. 3.Sleeve locating features (313, 323) are sized, shaped and configured toengage receiving feature (120) in place of locating feature (210) ofholster (200). In this instance, holster (200) and removable coverassembly (300) still becomes securely coupled to probe (100) despiteholster (200) being protectively contained within sleeves (310, 320).

As further seen in FIGS. 2-4, inner retainer (310) further includes arecess (311) positioned along the outer housing of inner retainer (310).Outer retainer (320) includes a tab (321) protruding inwardly away fromthe outer housing of outer retainer (320) and into outer retainerchannel (322). Tab (321) may be positioned along outer retainer (320) tocorrespond with the position of recess (311) on the outer housing ofinner retainer (310). Tab (321) is configured to releasably engagerecess (311) to thereby removably attach outer retainer (320) to innerretainer (310) when inner retainer (310) is slidably inserted withinouter retainer (320). Once engaged with each other, recess (311) isconfigured to releasably hold tab (321) until the operator exerts apredetermined releasing force on outer retainer (320) in the distaldirection, or alternatively on inner retainer (310) in the proximaldirection. Exerting the predetermined releasing force on either sleeve(310, 320) causes tab (321) to press against the perimeter walls ofrecess (311) until the protrusion of tab (321) is forced laterallyoutward from recess (311) thereby releasing outer retainer (320) fromthe secured engagement with inner retainer (310). At this point, innerretainer (310) may be slidably removed from outer retainer (320).

In the present example, recess (311) and tab (321) are positioned nearthe proximal end of sleeves (310, 320), respectively. It will beapparent to those of ordinary skill in the art that recess (311) and tab(321) may be positioned along the outer housing of sleeves (310, 320) atvarious other suitable positions. Alternatively, it should be understoodthat additional recesses (311) and tabs (321) may be included on sleeves(310, 320) than those shown. Furthermore, as seen in FIG. 4, recess(311) may be included on outer retainer (320) and tab (321) may beincluded on inner retainer (311). Although not shown, it should furtherbe understood that recess (311) and tab (321) may be in the form ofother various fastener configurations or operabilities that provide forthe releasable attachment of inner retainer (310) to outer retainer(320) as will be apparent to those of ordinary skill in the art in viewof the teachings herein.

FIG. 5 shows an exploded view of removable cover assembly (300) andholster (200). As previously discussed, holster (200) is slidablyreceived within inner retainer (310) through proximal inner retaineropening (314); which in turn is slidably received within outer retainer(320) through proximal outer retainer opening (324). In the presentexample, however, inner retainer (310) is slidably received withinflexible sterile cover (330), rather than directly into outer retainer(320). Flexible sterile cover (330) is sized and shaped to slidablyreceive and encase inner retainer (310) and holster (200) withoutrequiring an adhesion process. Once inner retainer (310) and holster(200) are fully encased within flexible sterile cover (330), flexiblesterile cover (330) may be slidably received within outer retainer(320). It should be understood that removable cover assembly (300) isfurther configured to be preassembled such that outer retainer (320),flexible sterile cover (330) and inner retainer (310) are respectivelyattached to each other prior to holster (200) being inserted intoremovable cover assembly (300). Although the present example is shown asincluding flexible sterile cover (330), it should be understood that insome examples flexible sterile cover (330) is omitted and only innerretainer (310) and outer retainer (320) are used with holster (200).

As will be described in greater detail below, flexible sterile cover(330) generally defines a negligible thickness such that flexiblesterile cover (330) does not inhibit coupling between probe (100) andholster (200). The term “negligible” used herein is used to refer tominimal interference between probe (100) and holster (200) such thatprobe (100) and holster (200) can still couple to each other through thethickness of outer sleeve (330). It should be understood that anegligible thickness may vary depending on a variety of factors such asthe space between probe (100) and holster (200) or the types ofcouplings used. For instance, in some examples flexible sterile cover(330) defines a thickness of about 0.048 mm. In other examples, flexiblesterile cover defines a thickness of 0.072 mm. Still in other examples,flexible sterile cover (330) defines a thickness of 0.08 mm. In yetother examples, flexible sterile cover (330) defines a relatively thickmaterial having a thickness of approximately 0.25 mm. In yet otherexamples, flexible sterile cover (330) defines a thickness of 3 mm orless. Regardless of the particular thickness of flexible sterile cover(330), it should be understood that flexible sterile cover (330) alsocomprises a material exhibiting elastomeric properties that permitflexible sterile cover (330) to bend, stretch, and contour aroundvarious geometric features of holster (200). Accordingly, incircumstances where flexible sterile cover (330) is stretched, it shouldbe understood that the thickness of flexible sterile cover (330) cancorrespondingly decrease in response to such stretching.

Flexible sterile cover (330) comprises a flexible sleeve channel (332),a proximal flexible sleeve opening (334), and a distal flexible sleeveend (336). Flexible sleeve channel (332) is contained within the outerlayer of flexible sterile cover (330) and is defined between proximalflexible sleeve opening (334) and distal flexible sleeve end (336).Proximal flexible sleeve opening (334) is sized and shaped to slidablyreceive holster (200) contained within inner retainer (310). Distalflexible sleeve end (336) is sized and shaped to contain inner retainer(310) while not interfering with the ability of inner retainer (310)from being slidably received within outer retainer (320).

Although not shown, it should be understood that in some instancesproximal flexible sleeve opening (334) can be equipped with a sleevering (335). A suitable sleeve ring (335) can be configured to promotemanipulation of proximal flexible sleeve opening (334) while stillpermitting access to flexible sleeve channel (322). One such suitablesleeve ring (335) can be a flange extending outwardly relative toflexible sleeve opening (334). Such a flange can provide a grippingsurface around the perimeter of flexible sleeve opening (334) to permitan operator to manipulate flexible sterile cover (330). In anothersuitable sleeve ring (335), such a sleeve ring can include an attachmentring and a manipulation grip. In such a sleeve ring, the attachment ringcan secure to the perimeter of flexible sleeve opening (334).Additionally, the manipulation grip can extend from at least a portionof the attachment ring to promote manipulation of flexible sterile cover(330) via the attachment ring. Of course, other suitable configurationsfor sleeve ring (335) can be used as will be apparent to those ofordinary skill in the art in view of the teachings herein.

Flexible sterile cover (330) may be formed of a material of latex,silicone, polyurethane, polyisoprene, nitrile, natural rubber or othervarious suitable materials that provide for a thin, flexible, durable,and sterile barrier between the sleeve's outer surface and innersurface. Flexible sterile cover (330) includes a thin thickness to anextent where the presence of flexible sterile cover (330) around innerretainer (310) and holster (200) is minimal and/or negligible. Thus, itshould be understood that flexible sterile cover (330) is generallyconfigured to surround locating feature (210) and retention feature(240) of holster (200) without substantially interfering with thecoupling between holster (200) and probe (100). Incorporating removablecover assembly (300) onto holster (200) eliminates the need for adding asterile barrier onto biopsy device (10) through an adhesion process,which can substantially reduce costs.

As best seen in FIG. 6 flexible sterile cover (330) has a longitudinallength greater than the longitudinal lengths of inner retainer (310) andholster (200) such that the proximal end (204) of holster (200) iscontained within proximal flexible sleeve opening (334) despite proximalend (204) extending beyond proximal sleeve openings (314, 324). In thepresent example, proximal flexible sleeve opening (334) extends beyondproximal end (204) to further encase a series of holster cables (222) tothereby allow the operator to maintain sterility of both holster (200)and holster cables (222). This may be beneficial as holster cables (222)are as likely to be exposed to non-sterile substances during a biopsyprocedure as holster (200). In some examples, the length of flexiblesterile cover (330) can be approximately two times the length of biopsydevice (10). In other examples, the length of flexible sterile cover(330) can be approximately three feet. In such examples, a length ofthree feet provides approximately two and a half feet of coverage ofholster cables (222). In either example, it is generally desirable tohave a sufficient length such that the coverage of flexible sterilecover (330) over holster cables (222) covers approximately the entirepatient window. In other words, the length of flexible sterile cover(330) is generally of sufficient length to avoid direct contact betweenholster cables (222) and the patient as well as other procedure roomequipment associated with the patient (e.g., the patient table). Ofcourse, other suitable lengths for flexible sterile cover (330) will beapparent to those of ordinary skill in the art in view of the teachingsherein.

By encompassing holster (200), flexible sterile cover (330) becomespositioned between the engagement mechanisms (120, 142) that allowholster (200) to couple with probe (100). In particular, flexiblesterile cover (330) is positioned on a distal end between locatingfeature (210) of holster (200) and the corresponding receiving feature(120) of probe (100). Similarly, flexible sterile cover (330) ispositioned on a proximal end between retention feature (240) of holster(200) and the corresponding catch (142) of probe (100).

However, as seen in FIG. 7, and as discussed above, flexible sterilecover (330) is formed of a thin, flexible material so as to notinterfere with the corresponding engagement of holster (200) to probe(100). As such, flexible sterile cover (330) is configured to allowholster (200) to effectively couple with probe (100) despite beingposition therebetween. In particular, locating feature (210) maintainsits ability to engage receiving feature (120) of probe (100) whileflexible sterile cover (330) encases inner retainer (310) and locatingfeature (210) of holster (200). Similarly, as seen in FIG. 8, retentionfeature (240) maintains its ability to engage catch (142) of probe (100)while flexible sterile cover (330) encases inner retainer (310) andretention feature (240) of holster (200).

To further facilitate coupling, in the present example probe (100) andholster (200) form a gap between each other when coupled together at thebottom surface of holster (200). In the present example, this gap isapproximately equivalent to the combined thickness of inner retainer(310), outer retainer (320), and flexible sterile cover (330). By way ofexample only, inner retainer (310) and outer retainer (320) can bothhave a thickness of approximately 1 mm. When combined with the thicknessof flexible sterile cover (330), the total combined thickness can be asmuch as 2.28 mm or as little as 2.048 mm. Thus, in some examples the gapdefined between probe (100) and holster (200) is at least 2.28 mm toaccommodate the maximum combined thickness of inner retainer (310),outer retainer (320), and flexible sterile cover (330). In otherexamples, the gap defined between probe (100) and holster (200) is atleast 2.048 mm to accommodate the minimum combined thickness of innerretainer (310), outer retainer (320), and flexible sterile cover (330).However, in some examples this gap can be increased even further thandescribed above to provide an oversized clearance fit between probe(100) and holster (200). In examples with such an oversized clearancefit, the gap can be as much as 2.4 mm. Of course, since the gap definedby probe (100) and holster (200) is related to the thicknesses ofsleeves (310, 320, 330), it should be understood that in examples whereany one or more of these thicknesses are varied, the gap between probe(100) and holster (200) can be correspondingly varied to accommodatedifferently sized sleeves (310, 320, 330).

FIG. 9 shows flexible sterile cover (330) positioned between outerretainer (320) and inner retainer (310). As seen, flexible sterile cover(330) is configured to allow inner retainer (310) to effectively slidewithin outer retainer channel (322) despite being positionedtherebetween. As best seen in FIG. 10, tab (321) of outer retainer (320)maintains its ability to engage recess (311) of inner retainer (310)while flexible sterile cover (330) encases inner retainer (310) andrecess (311).

Holster (200) of biopsy device (10) is configured to be a reusableportion while probe (100) is configured to be a disposable portion.Removable cover assembly (300) is thus configured to cover and protectholster (200) to maintain the sterility of holster (200) during a biopsyprocedure. Removable cover assembly (300) includes multiple layers ofshielding to maintain the sterility of holster (200), including outerretainer (320), flexible sterile cover (330) and inner retainer (310).

In an exemplary use, removable cover assembly (300) may be pre-assembledprior to a biopsy procedure. Pre-assembly may be completed by insertinginner retainer (310) into flexible sterile cover (330). Once innerretainer (310) is inserted therein, outer retainer (320) is insertedover the combination of flexible sterile cover (330) and inner retainer(310). Alternatively, the combination of flexible sterile cover (330)and inner retainer (310) is inserted into outer retainer (320). Ineither case, this causes tab (321) of outer retainer (320) to engagerecess (311) of inner retainer (310) to thereby secure inner retainer(310) to outer retainer (320) with flexible sterile cover (330) disposedtherebetween.

Once the components (310, 320, 330) of removable cover assembly (300)are assembled together, holster (200) may be slidably inserted intoremovable cover assembly (300) prior to attaching holster (200) to probe(100). Prior to insertion of holster (200), it should be understood thatflexible sterile cover (330) may be at least partially rolled around aportion of the proximal end of inner retainer (310). This configurationmay permit the interior of inner retainer (310) to be readily accessiblefor insertion of holster (200). Once holster (200) is inserted intoinner retainer (310), the rolled portion of flexible sterile cover (330)may be unrolled around holster and/or cables (222) extending fromholster (200).

The combination of removable cover assembly (300) and holster (200) isnext coupled to probe (100). As described above, despite removable coverassembly (300) enclosing outer housing (202) of holster (200), removablecover assembly (300) is configured to allow locating feature (210) andretention feature (240) of holster (200) to effectively engage probe(100) through flexible sterile cover (330). In this instance, proximalsleeve openings (314, 324) and distal sleeve openings (316, 326) areconfigured to allow locating feature (210) and retention feature (240),respectively, to attach holster (200) to probe (100) with holster (200)fully encased within removable cover assembly (300).

Once holder (200) is coupled to probe (100), a biopsy procedure may beinitiated. During such a biopsy procedure, it may be desirable tocontrol various operational functions of biopsy device (10) viaoperating panel (220) of holster (200). As described above, removablecover assembly (300) is configured to maintain the functionality ofoperating panel (220) of holster (200) with holster (200) encased inremovable cover assembly (300). Accordingly, in the present use topsleeve openings (318, 328) of removable cover assembly (300) provideaccessibility to operating panel (220) with holster (200) receivedwithin removable cover assembly (300). Additionally, flexible sterilecover (330) is configured to surround locating feature (210), retentionfeature (240) and operating panel (220) of holster (200) withoutsubstantially interfering with their respective functionalities.Accordingly, removable cover assembly (300) allows holster (200) tomaintain functionality while providing a shielding barrier over outerhousing (202) and cables (222) to maintain the sterility of holster(200) throughout the biopsy procedure.

III. Exemplary Alternative Sleeve Ring

As described above, in some examples it may be desirable to secure astructure such as sleeve ring (335) to flexible sterile cover (330) toprovide enhanced manipulation of flexible sterile cover (330). Asdescribed above, in some examples suitable sleeve rings may beconfigured as a simple flange. However, in some contexts additionalfeatures may be desirable. For instance, due to the flexible nature offlexible sterile cover (330), it may be desirable to equip suitablesleeve rings with fasteners, couplers, fittings, and/or etc. Inaddition, or in the alternative, in some contexts it may be desirable tocontrol excess material of flexible sterile cover (330), particularlywhen flexible sterile cover (330) is not being completely utilized.Thus, in some examples it may be desirable to use a portion of asuitable sleeve ring to control excess material associated with flexiblesterile cover (330).

Various examples of suitable sleeve rings similar to sleeve ring (335)are described below. Although certain specific examples are describedbelow of various suitable manipulation, it should be understood thatvarious alternative configurations may be used. In addition, to theextent that discrete features are described below in the context ofspecific embodiments, it should be understood that such features may becombined with other features in one or more alternative embodiments.Still other suitable sleeve rings will be apparent to those of ordinaryskill in the art in view of the teachings herein.

FIGS. 11 and 12 show an exemplary sleeve ring (435) or sleeve ring thatmay be readily used with flexible sterile cover (330) in lieu of sleevering (335) described above. Sleeve ring (435) is generally configuredfasten to flexible sterile cover (330) to enhance the manipulation offlexible sterile cover (330). Sleeve ring (435) includes a body (440)that defines a sheath portion (446) and a horn portion (450). Body (440)is generally configured to receive inner retainer (310). In particular,body (440) is shown as defining a hollow interior (442) that forms ad-shape that generally corresponds to the shape of inner retainer (310).Although body (440) is shown and described herein as having a particularshape, it should be understood that in other examples, the shape of body(440) can be modified to any other suitable shape corresponding to theshape of inner retainer (310).

Body (440) defines a relief slot (444) extending longitudinally alongthe length of body (440). Body (440) is generally comprises of a thinrelatively flexible material such as a plastic or polymer. Thus, body(440) has at least some flexibility. To further enhance thisflexibility, relieve slot (444) is generally configured to permit aportion of body (440) to fold over onto itself to thereby reduce thesize of body (440). As will be described in greater detail below, thisconfiguration is generally desirable to promote attachment of flexiblesterile cover (330) to sleeve ring (435).

Relief slot (444) includes an interlocking portion (445) defined by body(440) on either side of relief slot (444). As will be described ingreater detail below, interlocking portion (445) is generally configuredto provide some rigidity to body (440) when body (440) is compressed toclose relieve slot (444). In the present example, interlocking portion(445) includes a tongue and groove configuration comprising a triangulartongue and corresponding triangular groove. In other examples, othersuitable interlocking features can be used such as a square tongue and asquare groove, a rounded tongue and a rounded groove, and/or etc.

Sheath portion (446) defines a substantial portion of the longitudinallength of body (440). Sheath portion (446) is generally configured tohold a portion of flexible sterile cover (330) in a compressed or foldedconfiguration. As will be described in greater detail below, thisfeature may be desirable to manage excess portions of flexible sterilecover (330) when flexible sterile cover (330) is not in use. Sheathportion (446) can define a variety of suitable lengths. For instance, insome examples sheath portion (446) is approximately equivalent to ⅓ ofthe length of holster (200). In still other examples, sheath portion(446) is approximately equivalent to ¼ of the length of holster (200).Still other suitable lengths of sheath portion (446) will be apparent tothose of ordinary skill in the art in view of the teachings herein.

Horn portion (450) extends proximally and outwardly relative to sheathportion (446). As can be seen, horn portion (450) provides a generallyfrustoconical shape. In other words, horn portion (450) is generallyflared outwardly relative to sheath portion (446). This configurationprovides an enlargement of hollow interior (442) of body (440) tothereby enhance access to hollow interior (442). As will be described ingreater detail below, enhanced access may be desirable to aid ininserting components such as inner retainer (310) and/or holster (200)into sleeve ring (435) and into flexible sterile cover (330).Additionally, the flared nature of horn portion (450) provides enhancedgripping of sleeve ring (435) to thereby enhance manipulation offlexible sterile cover (330).

Sleeve ring (435) further includes a plurality of tabs (452, 458)extending proximally and outwardly from body (440) near the interfacebetween sheath portion (446) and horn portion (450). Tabs (452, 458) aregenerally configured to grip at least a portion of flexible sterilecover (330) to provide releasable attachment between sleeve ring (435)and flexible sterile cover (330). As will be described in greater detailbelow, flexible sterile cover (330) generally extends distally fromsleeve ring (435) when attached thereto. Thus, tabs (452, 458) extend ina proximal direction relative to body (440) while also extendingoutwardly. This configuration permits a portion of flexible sterilecover (330) to fold over and underneath tabs (452, 458) to releasablyhold flexible sterile cover (330) in position.

In the present example, tabs (452, 458) include a pair of upper tabs(452) and a single lower tab (458). Lower tabs (452) are positioned atthe upper inflexion points in the shape of body (440). Meanwhile lowertab (458) is positioned at the lower inflexion point in the shape ofbody (440). Although upper tabs (452) and lower tab (458) are describedseparately herein, it should be understood that upper tabs (452) andlower tab (458) are generally substantially similar to each other exceptas where otherwise noted herein.

Beneath each tab (452, 458), body (440) defines an opening (454, 460)associated with each tab (452, 458). Openings (454, 560) are generallyconfigured to provide additional clearance that permits flexible sterilecover (330) to fully engage each tab (452, 458). For instance, in theabsence of openings (454, 460), the curvature of horn portion (450)could potentially interfere with engagement between flexible sterilecover (330) and tabs (452, 458) by flexible sterile cover (330) ridingup the curvature of horn portion (450).

Openings (454, 460) include a pair of upper openings (454) and a singlelower opening (460). Upper openings (454) are associated with upper tabs(452). Meanwhile, lower opening (460) is associated with lower tab(458). Each upper opening (454) is enclosed on all four sides of therectangular shape defined by each upper opening (454). Thisconfiguration is generally due to the curvature of horn portion (450) inthe area associated with upper openings (454). In particular, since thecurvature of horn portion (450) is relatively steep in the areaassociated with upper openings (454), it is desirable to entirelyenclose upper openings (454). Meanwhile, the proximal face of loweropening (460) is open due to the relatively low slope of the curvatureof horn portion (450) in the area associated with lower opening (460).

FIGS. 13-15 show an exemplary use of sleeve ring (435). As seen in FIG.13, sleeve ring (435) can be initially manipulated to flex body (440) tocollapse on itself via relief slot (444). This causes one of the edgesthat defines relief slot (444) to fold under another edge. As aconsequence, the overall size of sleeve ring (435) is reduced. Thisreduction in size can make it easier for an operator to stretch flexiblesterile cover (330) over sheath portion (446) of body (440). AlthoughFIG. 13 only shows a relatively small amount of flexion, it should beunderstood that sleeve ring (435) can be flexed any suitable amountdepending on a variety of factors such as the elasticity of flexiblesterile cover (330), the size and/or shape of flexible sterile cover(330), the relative strength of the operator, and/or etc. For instance,in some examples, sleeve ring (435) can be flexed until an edge definingrelief slot (444) touches the opposite inflexion point or corner formedby body (440). Thus, the width of sleeve ring (435) can be reducedapproximately in half in some uses. Of course, various alternativeamounts of flexion can be used as will be apparent to those of ordinaryskill in the art in view of the teachings herein.

Once sleeve ring (435) is flexed as desired by an operator, flexiblesterile cover (330) can be slid over sheath portion (446) and intoengagement with tabs (452, 458). As seen in FIG. 14, when flexiblesterile cover (330) is secured onto sleeve ring (435), a portion offlexible sterile cover (330) can be manipulated to rest in the spacebeneath each tab (452, 458). As described above, full engagement betweenflexible sterile cover (330) and each tab (452, 458) is permitted byopenings (454, 560), which prevent interference from horn portion (450).It should be understood that in some examples the proximal end offlexible sterile cover (330) can be rolled or can include a radial ribthat can rest beneath each tab (452, 458) to provide additional support.

As also shown in FIG. 14, once flexible sterile cover (330) is securedto sleeve ring (435), body (440) can be decompressed to open relief slot(444). Once relief slot (444) is open, the resiliency of flexiblesterile cover (330) causes relief slot (444) to close on itself, therebyengaging interlocking portion (445). In the present example, thetriangular tongue of interlocking portion (445) engages the triangulargroove of interlocking portion (445) to provide additional structuralrigidity to body (440). Although this decompression step is shown asoccurring after flexible sterile cover (330) is initially attached tosleeve ring (435), it should be understood that this step can be insteadperformed later in the procedure, as will be described in greater detailbelow.

As seen in FIG. 15, once flexible sterile cover (330) is initiallysecured to sleeve ring (435), excess length of flexible sterile cover(330) can be rolled or compressed onto the length defined by sheathportion (446). For example, the excess length can be rolled or foldedonto the sleeve ring (435) in a zig-zag accordion-like manner or foldedover each other. Thus, in the present use sheath portion (446) can beused to store any excess length of flexible sterile cover (330) untiluse of flexible sterile cover (330) is desired. As described above, thisfeature may be desirable in certain contexts to make the assembly offlexible sterile cover (330) and sleeve ring (435) easier to manipulatebefore the entire length of flexible sterile cover (330) is needed.

As also shown in FIG. 15, once flexible sterile cover (330) is rolled orcompressed onto the length defined by sheath portion (446), body (440)can be decompressed to open relief slot (444). Once relief slot (444) isopen, the resiliency of flexible sterile cover (330) causes relief slot(444) to close on itself, thereby engaging interlocking portion (445).As described above, this decompression procedure can be performed afterflexible sterile cover (330) is initially secured to sleeve ring (435).Alternatively, this decompression procedure can be performed only afterflexible sterile cover (330) is rolled or compressed onto the lengthdefined by sheath portion (446). In some circumstances, the latterapproach may be desirable to make the procedure of rolling and/orcompressing flexible sterile cover (330) easier due to the decreasedsize of sleeve ring (435).

An operator can next insert inner retainer (310) or a combination ofinner retainer (310) and holster (200) into flexible sterile cover (330)via hollow interior (442) of sleeve ring (435). Although this step canbe performed regardless of whether flexible sterile cover (330) is inthe unrolled position (FIG. 14) or rolled position (FIG. 15), the rolledposition is generally more desirable because inner retainer (310) willnot have to travel as far through flexible sterile cover (330) beforereaching the distal end of flexible sterile cover (330).

Once inner retainer (310) and holster (200) are inserted into flexiblesterile cover (330), external sleeve (320) can be secured to innerretainer (310) with flexible sterile cover (330) disposed between innerretainer (310) and outer retainer (320). Sleeve ring (435) can then beused to manipulate the proximal end of flexible sterile cover (330) downthe length of holster cables (222). As described above, the length offlexible sterile cover (330) can generally be sized to provideapproximately 2.5 feet of coverage of holster cables (222), althoughthis length may be varied in other examples.

FIGS. 16 and 17 show a use of sleeve ring (435) with inner retainer(310), outer retainer (320), and flexible sterile cover (330). It shouldbe understood that the state shown in FIGS. 16 and 17 corresponds to theassembly being in a shipped or packaged state. In other words, when anoperator first removes the combination of sleeve ring (435), innerretainer (310), outer retainer (320), and flexible sterile cover (330)from sterile packaging, the combination can be in the state shown inFIGS. 16 and 17. As can be seen, in the packaged state, inner retainer(310) is nested within outer retainer (320). Flexible sterile cover(330) is positioned between inner retainer (310) and outer retainer(320). As can be seen, flexible sterile cover (330) is visible throughtop sleeve openings (318, 328). At least a portion of flexible sterilecover (330) is covered by outer retainer (320) before emerging fromproximal sleeve opening (324). At this point, at least a portion offlexible sterile cover (330) can be folded distally over outer retainer(320). Flexible sterile cover (330) then passes proximally over innerretainer (310) until reaching sleeve ring (435). At sleeve ring (435),flexible sterile cover (330) is compressed, rolled, folded, or bunchedover sheath portion (446), as described above. In this configuration,the combination of sleeve ring (435), inner retainer (310), outerretainer (320), and flexible sterile cover (330) is generally configuredto readily receive holster (200) with minimal manipulation and/oradjustment by an operator.

Once an operator places holster (200) within the combination of sleevering (435), inner retainer (310), outer retainer (320), and flexiblesterile cover (330), the operator can pull sleeve ring (435) proximallyaway from holster (200) along holster cables (222). This can causeflexible sterile cover (330) to unroll, decompress, or otherwise extendin length as flexible sterile cover (330) is pulled off of sheathportion (446).

IV. Exemplary Combinations

The following examples relate to various non-exhaustive ways in whichthe teachings herein may be combined or applied. It should be understoodthat the following examples are not intended to restrict the coverage ofany claims that may be presented at any time in this application or insubsequent filings of this application. No disclaimer is intended. Thefollowing examples are being provided for nothing more than merelyillustrative purposes. It is contemplated that the various teachingsherein may be arranged and applied in numerous other ways. It is alsocontemplated that some variations may omit certain features referred toin the below examples. Therefore, none of the aspects or featuresreferred to below should be deemed critical unless otherwise explicitlyindicated as such at a later date by the inventors or by a successor ininterest to the inventors. If any claims are presented in thisapplication or in subsequent filings related to this application thatinclude additional features beyond those referred to below, thoseadditional features shall not be presumed to have been added for anyreason relating to patentability.

Example 1

A biopsy device, comprising: (a) a body; (b) a needle extending from thebody; and (c) a sterile cover assembly releasably coupled to the body,wherein the sterile cover assembly is configured to substantially coverthe body, wherein the sterile cover assembly includes: (i) a first rigidsleeve, wherein the first rigid sleeve is configured to receive thebody; (ii) a second flexible sleeve, wherein the second flexible sleeveis configured to receive the first rigid sleeve with the body containedtherein; and (iii) a third rigid sleeve, wherein the third rigid sleeveis configured to receive the second flexible sleeve with the first rigidsleeve and the body contained therein.

Example 2

The biopsy device of Example 1, wherein the first rigid sleeve and thethird rigid sleeve include each an interface opening, a distal opening,and a proximal opening.

Example 3

The biopsy device of Example 2, wherein the first rigid sleeve and thirdrigid sleeve further each include an inner channel extending between thedistal opening and the proximal opening.

Example 4

The biopsy device of Example 3, wherein the inner channel of the firstrigid sleeve is sized and shaped to receive the body, wherein a firstlength of the body is greater than a second length of the inner channelof the first rigid sleeve such that the body extends proximally from theproximal opening of the first rigid sleeve when the body is receivedwithin the inner channel of the first rigid sleeve.

Example 5

The biopsy device of Example 3, wherein the inner channel of the thirdrigid sleeve is sized and shaped to receive the first rigid sleeve,wherein the second length of the inner channel of the first rigid sleeveis greater than a third length of the inner channel of the third rigidsleeve such that the first rigid sleeve extends proximally from theproximal opening of the third rigid sleeve when the first rigid sleeveis received within the inner channel of the third rigid sleeve.

Example 6

The biopsy device of Example 2, wherein the interface opening of thefirst rigid sleeve is configured to align with the interface opening ofthe third rigid sleeve when the first rigid sleeve is received withinthe third rigid sleeve.

Example 7

The biopsy device of Example 6, wherein the interface openings of thefirst and third rigid sleeves are located along the first and thirdrigid sleeves in a position that corresponds with an interface surfaceof the body such that the interface surface remains operativelyaccessible after the body is received within the first and third rigidsleeves.

Example 8

The biopsy device of Example 5, wherein the body further includes adistal end and a proximal end, wherein the distal and proximal ends areconfigured to couple the body to the biopsy device.

Example 9

The biopsy device of Example 5, wherein the distal and proximal openingsof the first and third rigid sleeves are configured to align with distaland proximal ends of the body to thereby allow the body to couple to aportion of the biopsy device when the body is received within the firstand third rigid sleeves.

Example 10

The biopsy device of Examples 1 through 9, wherein the second flexiblesleeve is formed of a latex material and has a negligible thickness.

Example 11

The biopsy device of Example 10, wherein the second flexible sleeveincludes a distal closed end, a proximal open end, and a flexible innerchannel.

Example 12

The biopsy device of Example 11, wherein a fourth length of the flexibleinner channel is greater than the first length of the body such that thesecond flexible sleeve extends proximally from the proximal opening ofthe first rigid sleeve and the proximal end of the body when the firstrigid sleeve and the body are received within the flexible inner channelof the second flexible sleeve.

Example 13

The biopsy device of Example 12, wherein the negligible thickness of thesecond flexible sleeve is configured to allow the distal end of the bodyto couple with a portion of the biopsy device when the body is receivedwithin the second flexible sleeve.

Example 14

The biopsy device of Example 13, wherein the distal closed end of thesecond flexible sleeve is located along the second flexible sleeve in aposition that corresponds with the proximal openings of the first andthird rigid sleeves and the proximal end of the body.

Example 15

The biopsy device of Example 14, wherein the negligible thickness of thesecond flexible sleeve is configured to allow the proximal end of thebody to couple with a portion of the biopsy device when the body isreceived within the second flexible sleeve.

Example 16

The biopsy device of any one or more of Examples 1 through 15, furthercomprising a sleeve ring secured to a distal end of the second flexiblesleeve, wherein the sleeve ring is configured to promote manipulation ofthe second flexible sleeve.

Example 17

The biopsy device of Example 16, wherein the sleeve ring includes aflange extending outwardly from the distal end of the second flexiblesleeve.

Example 18

A biopsy device comprising: (a) a body; (b) a needle extending from thebody; and (c) a removable cover assembly coupled to the body, whereinthe removable cover assembly is configured to substantially cover thebody, wherein the removable cover assembly includes: (i) an internalsleeve configured to slidably receive the body at a proximal end,wherein the body remains partially exposed on a distal end when fullyreceived by the internal sleeve, wherein the internal sleeve includes apair of notches; (ii) an external sleeve configured to slidably receivethe internal sleeve at the proximal end, wherein the internal sleeveremains partially exposed on the distal end when fully received by theexternal sleeve, wherein the external sleeves include a pair ofresilient latches; and wherein the pair of resilient latches areconfigured to releasably engage the pair of notches when the internalsleeve is slidably received within the external sleeve.

Example 19

The biopsy device of Example 18, wherein the internal sleeve and theexternal sleeve both include an interface opening, a distal opening, anda proximal opening.

Example 20

The biopsy device of Example 19, wherein the interface opening of theinternal sleeve is configured to align with the interface opening of theexternal sleeve when the internal sleeve is received within the externalsleeve.

Example 21

A biopsy device, comprising: (a) a body; (b) a needle extending from thebody; and (c) a sterile cover assembly releasably coupled to the body,wherein the sterile cover assembly is configured to substantially coverthe body, wherein the sterile cover assembly includes: (i) a first rigidsleeve, wherein the first rigid sleeve is configured to receive at leasta portion of the body, (ii) a second flexible sleeve, wherein the secondflexible sleeve is configured to receive the first rigid sleeve with thebody contained therein, and (iii) a third rigid sleeve, wherein thethird rigid sleeve is configured to receive the second flexible sleevewith the first rigid sleeve and the body contained therein.

Example 22

The biopsy device of Example 21, wherein the first rigid sleeve and thethird rigid sleeve both include an interface opening, a distal opening,and a proximal opening.

Example 23

The biopsy device of Example 21, wherein the first rigid sleeve and thethird rigid sleeve both include an interface opening, a distal opening,a proximal opening, and an inner channel extending between the distalopening and the proximal opening.

Example 24

The biopsy device of Example 21, wherein the first rigid sleeve and thethird rigid sleeve both include an interface opening, a distal opening,a proximal opening, and an inner channel extending between the distalopening and the proximal opening, wherein the inner channel of the firstrigid sleeve is sized and shaped to receive the body, wherein a firstlength of the body is greater than a second length of the inner channelof the first rigid sleeve such that the body extends proximally from theproximal opening of the first rigid sleeve when the body is receivedwithin the inner channel of the first rigid sleeve.

Example 25

The biopsy device of Example 21, wherein the first rigid sleeve and thethird rigid sleeve both include an interface opening, a distal opening,a proximal opening, and an inner channel extending between the distalopening and the proximal opening, wherein the inner channel of the thirdrigid sleeve is sized and shaped to receive the first rigid sleeve,wherein a length defined by the inner channel of the first rigid sleeveis greater than a length defined by the inner channel of the third rigidsleeve such that the first rigid sleeve extends proximally from theproximal opening of the third rigid sleeve when the first rigid sleeveis received within the inner channel of the third rigid sleeve.

Example 26

The biopsy device of Example 21, wherein the first rigid sleeve and thethird rigid sleeve both include an interface opening, a distal opening,and a proximal opening, wherein the interface opening of the first rigidsleeve is configured to align with the interface opening of the thirdrigid sleeve when the first rigid sleeve is received within the thirdrigid sleeve.

Example 27

The biopsy device of Example 21, wherein the first rigid sleeve and thethird rigid sleeve both include an interface opening, a distal opening,and a proximal opening, wherein the interface opening of the first rigidsleeve is configured to align with the interface opening of the thirdrigid sleeve when the first rigid sleeve is received within the thirdrigid sleeve, wherein the interface openings of the first and thirdrigid sleeves are located along the first and third rigid sleeves in aposition that corresponds with an interface surface of the body suchthat the interface surface remains operatively accessible after the bodyis received within the first and third rigid sleeves.

Example 28

The biopsy device of Example 21, wherein the body is defined by a probeand a holster, wherein the first rigid sleeve is configured to receivethe holster, wherein the holster includes a distal and proximal end,wherein the distal and proximal ends of the holster are configured tocouple to the probe through a portion of the second flexible sleeve.

Example 29

The biopsy device of Example 21, wherein the first rigid sleeve and thethird rigid sleeve both include a distal opening, a proximal opening,and an inner channel extending between the distal opening and theproximal opening, wherein a length defined by the inner channel of thefirst rigid sleeve is greater than a length defined by the inner channelof the third rigid sleeve such that the first rigid sleeve extendsproximally from the proximal opening of the third rigid sleeve when thefirst rigid sleeve is received within the inner channel of the thirdrigid sleeve, wherein the body is defined by a probe and a holster,wherein the first rigid sleeve is configured to receive the holster,wherein the holster includes a distal and proximal end, wherein thedistal and proximal openings of the first and third rigid sleeves areconfigured to align with the distal and proximal ends of the holstersuch that the holster is configured to couple to the probe when theholster is received within the first and third rigid sleeves.

Example 30

The biopsy device of Example 21, wherein the second flexible sleeve isformed of a latex material and has a negligible thickness, wherein thesecond flexible sleeve includes a distal closed end, a proximal openend, and a flexible inner channel.

Example 31

The biopsy device of Example 21, wherein the second flexible sleeveincludes a distal closed end, a proximal open end, and a flexible innerchannel, wherein a length defined by the flexible inner channel isgreater than a length defined by the body such that the second flexiblesleeve extends proximally from a proximal end of the body when the firstrigid sleeve and the body are received within the flexible inner channelof the second flexible sleeve.

Example 32

The biopsy device of Example 21, wherein the body is defined by a probeand a holster, wherein the first rigid sleeve is configured to receivethe holster, wherein the holster includes a distal and proximal end,wherein the second flexible sleeve is formed of a latex material and hasa negligible thickness, wherein the negligible thickness of the secondflexible sleeve is configured to permit the distal end of the holster tocouple with a portion of the probe through the second flexible sleeve.

Example 33

The biopsy device of Example 32, wherein the negligible thickness of thesecond flexible sleeve is configured to permit the proximal end of theholster to couple with a portion of the probe through the secondflexible sleeve.

Example 34

The biopsy device of Example 21, further comprising a sleeve ringsecured to a distal end of the second flexible sleeve, wherein thesleeve ring is configured to promote manipulation of the second flexiblesleeve.

Example 35

The biopsy device of Example 34, wherein the sleeve ring includes aflange extending outwardly from the distal end of the second flexiblesleeve.

Example 36

A biopsy device comprising: (a) a body; (b) a needle extending from thebody; and (c) a removable cover assembly coupled to the body, whereinthe removable cover assembly is configured to substantially cover thebody, wherein the removable cover assembly includes: (i) an internalsleeve configured to receive the body at a proximal end, wherein thebody remains partially exposed on a distal end when fully received bythe internal sleeve, wherein the internal sleeve includes a pair ofnotches, and (ii) an external sleeve configured to receive the internalsleeve at the proximal end, wherein the internal sleeve remainspartially exposed on the distal end when fully received by the externalsleeve, wherein the external sleeves include a pair of resilientlatches, wherein the pair of resilient latches are configured toreleasably engage the pair of notches when the internal sleeve isreceived within the external sleeve.

Example 37

The biopsy device of Example 36, wherein the removable cover assemblyfurther comprises a flexible sleeve, wherein the flexible sleeve definesa closed distal end and an open proximal end, wherein the open proximalend of the flexible sleeve is configured to receive the internal sleeve.

Example 38

The biopsy device of Example 36, wherein the removable cover assemblyfurther comprises a flexible sleeve, wherein the flexible sleeve definesa longitudinal length, wherein the body defines a longitudinal length,wherein the longitudinal length of the flexible sleeve is greater thanthe longitudinal length of the body.

Example 39

The biopsy device of Example 36, wherein the removable cover assemblyfurther comprises a flexible sleeve, wherein the flexible sleeve definesa closed distal end, an open proximal end, and a manipulator, whereinthe manipulator is secured to the open proximal end, wherein themanipulator defines an opening therein configured to permit access tothe open proximal end.

Example 40

A system for maintaining sterility of a biopsy device, the biopsy deviceincluding a probe and a holster, wherein the system comprises: (a) aninner cover, wherein the inner cover is configured to receive theholster of the biopsy device; (b) an outer cover, wherein the outercover is configured to receive the inner cover, wherein the outer coverincludes a fastener with the fastener being configured to removablycouple the inner cover to the outer cover; and (c) a flexible sleeve,wherein the sterile cover is configured to be received between the innercover and the outer cover, wherein the flexible sleeve defines athickness that is configured to permit the fastener of the outer coverto engage the inner cover through a portion of the flexible sleeve.

IV. Miscellaneous

It should be appreciated that any patent, publication, or otherdisclosure material, in whole or in part, that is said to beincorporated by reference herein is incorporated herein only to theextent that the incorporated material does not conflict with existingdefinitions, statements, or other disclosure material set forth in thisdisclosure. As such, and to the extent necessary, the disclosure asexplicitly set forth herein supersedes any conflicting materialincorporated herein by reference. Any material, or portion thereof, thatis said to be incorporated by reference herein, but which conflicts withexisting definitions, statements, or other disclosure material set forthherein will only be incorporated to the extent that no conflict arisesbetween that incorporated material and the existing disclosure material.

Embodiments of the present invention have application in conventionalendoscopic and open surgical instrumentation as well as application inrobotic-assisted surgery.

By way of example only, embodiments described herein may be processedbefore surgery. First, a new or used instrument may be obtained and ifnecessary cleaned. The instrument may then be sterilized. In onesterilization technique, the instrument is placed in a closed and sealedcontainer, such as a plastic or TYVEK bag. The container and instrumentmay then be placed in a field of radiation that can penetrate thecontainer, such as gamma radiation, x-rays, or high-energy electrons.The radiation may kill bacteria on the instrument and in the container.The sterilized instrument may then be stored in the sterile container.The sealed container may keep the instrument sterile until it is openedin a medical facility. A device may also be sterilized using any othertechnique known in the art, including but not limited to beta or gammaradiation, ethylene oxide, or steam.

Embodiments of the devices disclosed herein can be reconditioned forreuse after at least one use. Reconditioning may include any combinationof the steps of disassembly of the device, followed by cleaning orreplacement of particular pieces, and subsequent reassembly. Inparticular, embodiments of the devices disclosed herein may bedisassembled, and any number of the particular pieces or parts of thedevices may be selectively replaced or removed in any combination. Uponcleaning and/or replacement of particular parts, embodiments of thedevices may be reassembled for subsequent use either at a reconditioningfacility, or by a surgical team immediately prior to a surgicalprocedure. Those skilled in the art will appreciate that reconditioningof a device may utilize a variety of techniques for disassembly,cleaning/replacement, and reassembly. Use of such techniques, and theresulting reconditioned device, are all within the scope of the presentapplication.

Having shown and described various embodiments of the present invention,further adaptations of the methods and systems described herein may beaccomplished by appropriate modifications by one of ordinary skill inthe art without departing from the scope of the present invention.Several of such potential modifications have been mentioned, and otherswill be apparent to those skilled in the art. For instance, theexamples, embodiments, geometrics, materials, dimensions, ratios, steps,and the like discussed above are illustrative and are not required.Accordingly, the scope of the present invention should be considered interms of the following claims and is understood not to be limited to thedetails of structure and operation shown and described in thespecification and drawings.

I/We claim:
 1. A sterile cover assembly for a biopsy device having areusable holster including a housing and driving mechanism for driving acutter in a needle of a probe, the housing adapted to releasably coupleto the probe, the sterile cover assembly comprising: a sleeve, whereinthe sleeve is configured to receive at least a portion of the housing ofthe reusable holster; and a flexible sterile cover coupled to the sleeveand configured to cover the housing of the holster.
 2. The sterile coverassembly of claim 1, wherein the sleeve includes an interface opening, adistal opening, a proximal opening, and an inner channel extendingbetween the distal opening and the proximal opening, wherein theinterface opening is configured to provide access to one or more buttonson the housing of the holster through the flexible sterile cover.
 3. Thesterile cover assembly of claim 1, wherein the sleeve includes aninterface opening, a distal opening, a proximal opening, and an innerchannel extending between the distal opening and the proximal opening,wherein the interface opening is configured to provide access to one ormore buttons on the housing of the holster through the flexible sterilecover, wherein the inner channel of the sleeve is sized and shaped toreceive the holster, wherein a first length of the sleeve is less than asecond length of the holster such that a portion of the holster extendsproximally from the proximal opening of the sleeve when the holster isreceived within the inner channel of the sleeve.
 4. The sterile coverassembly of claim 1, wherein the sleeve includes an outer retainer andan inner retainer, wherein the inner retainer is configured to nestwithin the outer retainer so as to sandwich the flexible sterile covertherebetween.
 5. The sterile cover assembly of claim 1, wherein thesleeve includes an outer retainer and an inner retainer configured tonest within the outer retainer so as to sandwich the flexible sterilecover therebetween, wherein each of the outer and inner retainersincludes an interface opening, wherein the interface opening of theouter retainer is configured to align with the interface opening of theinner retainer to permit access to one or more buttons on the housing ofthe holster through the outer retainer, the flexible sterile cover, andthe inner retainer.
 6. The sterile cover assembly of claim 1, whereinthe flexible sterile cover is configured to cover a cable extending fromthe holster for a predetermined length, wherein the predetermined lengthis at least one foot.
 7. The sterile cover assembly of claim 1, whereinthe sleeve includes an outer retainer and an inner retainer configuredto nest within the outer retainer so as to sandwich the flexible sterilecover therebetween, wherein the length of each of the outer retainer andthe inner retainer is less than the length of the holster such that theouter retainer and the inner retainer only cover a portion of theholster when the holster is received within the inner retainer and theouter retainer.
 8. The sterile cover assembly of claim 1, wherein theflexible sterile cover includes a latex sterile cover that has athickness of 3 mm or less.
 9. The sterile cover assembly of claim 1,wherein the flexible sterile cover includes a distal closed end, aproximal open end, and an inner channel, wherein a length defined by theinner channel is greater than a length defined by the holster such thatthe flexible sterile cover extends proximally from a proximal end of theholster when the sleeve and the holster are received within the innerchannel of the flexible sterile cover.
 10. The sterile cover assembly ofclaim 1, further comprising a sleeve ring attached to a proximal end ofthe flexible sterile cover and at least a portion of the flexiblesterile cover is disposed on the outside of the sleeve ring in a rolledconfiguration to be unrolled over the housing of the holster by a user.11. The sterile cover assembly of claim 1, wherein the sleeve includesan outer retainer and an inner retainer, wherein the inner retainer isconfigured to nest within the outer retainer so as to sandwich theflexible sterile cover therebetween, further comprising a sleeve ringattached to a proximal end of the flexible sterile cover and at least aportion of the flexible sterile cover is disposed on the outside of thesleeve ring in a rolled configuration to be unrolled over the housing ofthe holster by a user, wherein the flexible sterile cover extendsproximally from the distal end of the sleeve between the outer and innerretainer, then distally over the outer retainer, then proximally overthe sleeve ring.
 12. The sterile cover assembly of claim 1, furthercomprising a sleeve ring attached to a proximal end of the flexiblesterile cover to allow manipulation of the flexible sterile cover tocover the housing of the holster.
 13. The sterile cover assembly ofclaim 1, further comprising a sleeve ring defining a sheath portion anda horn portion, wherein the sheath portion is configured to receive theflexible sterile cover in a rolled configuration, wherein the hornportion is flared relative to the sheath portion.
 14. The sterile coverassembly of claim 1, further comprising a sleeve ring defining a tab andan opening disposed adjacent to the tab, wherein the tab and the openingare configured to releasably receive a proximal end of the flexiblesterile cover.
 15. The sterile cover assembly of claim 1, furthercomprising a sleeve ring configured to releasably couple to a proximalend of the flexible sterile cover to manipulate the proximal end of theflexible sterile cover, wherein the sleeve ring is an open ring andincludes a locking relief slot to permit the sleeve ring to flex toreduce the ring size and to increase the ring size when the lockingrelief slot is locked.
 16. A biopsy device comprising: (a) a holster;(b) a probe configured to couple to the holster; (c) a needle extendingfrom the probe; and (d) a removable cover assembly couplable to theholster, wherein the removable cover assembly is configured tosubstantially cover the holster, wherein the removable cover assemblyincludes: (i) an inner sleeve retainer configured to receive a portionof the body, (ii) an outer sleeve retainer configured to receive theinner sleeve retainer, and (iii) a flexible sterile cover configured tocover a portion of the body, wherein the inner sleeve retainer isconfigured to nest within the outer sleeve retainer so as to sandwichthe flexible sterile cover therebetween.
 17. The biopsy device of claim16, wherein the removable cover assembly further includes a sleeve ringconfigured to fasten to a proximal end of the flexible sterile cover,wherein the sleeve ring defines a d-shaped cross-section configured toencompass the inner sleeve retainer and the outer sleeve retainer. 18.The biopsy device of claim 16, wherein the removable cover assemblyfurther includes a sleeve ring defining a plurality of tabs, whereineach tab of the plurality of tabs is configured to engage a proximal endof the flexible sterile cover to fasten the flexible sterile cover tothe sleeve ring.
 19. The biopsy device of claim 16, wherein theremovable cover assembly further includes a flexible sleeve, wherein theflexible sleeve defines a closed distal end, an open proximal end, and amanipulator, wherein the manipulator is configured to releasably secureto the open proximal end of the flexible sleeve, wherein the manipulatordefines an opening therein configured to permit access to the openproximal end of the flexible sleeve.
 20. A method for providing asterile barrier to a biopsy device, the biopsy device including aholster and a probe with a needle extending distally from the probe, themethod comprising: (a) providing a sterile cover assembly in a packagedcondition, wherein the sterile cover assembly in the packaged conditionincludes a flexible cover attached to a sleeve ring, wherein a portionof the flexible cover is compressed over a portion of the sleeve ring;(b) inserting the holster of the biopsy device into the flexible coverthrough an opening in the sleeve ring; (c) pulling the sleeve ringproximally relative to the holster to decompress the flexible cover fromthe sleeve ring; and (d) attaching the probe to the holster while theholster is disposed within the flexible cover.